NCT01726335

Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia

An Open-Label Study of Oral Antipsychotics Replacement by Prolonged Release Risperidone (Risperdal Consta) in Schizophrenic Subjects With Bad Adhesion to the Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Janssen-Cilag Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate efficacy, safety and tolerance of long-acting risperidone when switching from oral antipsychotics in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Detailed description

This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of long-acting risperidone in participants with schizophrenia who have a previous history (in the last 12 months) of bad adherence to the oral antipsychotic treatment of first or second generation. The duration of this study will be 24 weeks and will include following visits: Screening, Baseline, Week 2, 4, 8, 12, 16, 20, 24, 38 and 50 (End visit or early withdrawal). All the eligible participants (after risperidone intolerance test during screening) will receive a dose of 25 milligram risperidone every two weeks by intramuscular injection (injection of a substance into a muscle). Efficacy and safety of the participants will primarily be evaluated by Positive and Negative Syndromes Scale and Extrapyramidal Symptom Rating Scale, respectively. Participants' safety will be monitored throughout the study.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Risperidone prolonged release	Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3.

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2012-11-14
• Last updated: 2014-04-29
• Results posted: 2013-07-24

Locations

5 sites across 1 country: Brazil